三家 CDMO 加入 BioTools Innovator 与 BARDA 合作项目，试点扩展现实生物制药上岗培训

Three contract development and manufacturing organizations (CDMOs) are partnering with developers of virtual- and augmented-reality training tools as part of a program designed to evaluate the effectiveness of extended reality (XR) technologies for onboarding biopharmaceutical manufacturing technicians.

Jubilant HollisterStier (JHS), KBI Biopharma, and Kindeva were selected to participate in the BioTools Innovator (BTI) Vanguard Level UP-XR program, which pairs CDMOs with companies supplying XR technologies to test immersive training platforms in Good Manufacturing Practice (GMP) environments.

The initiative provides up to $300,000 in non-dilutive funding for each of three partnerships to develop, implement, and evaluate training pilots lasting up to 12 months. The Vanguard program is a collaboration between BioTools Innovator and the Biomedical Advanced Research and Development Authority (BARDA).

Through the program, KBI and Kindeva are partnering with Prism Immersive, while JHS will collaborate with Altoura, both of which offer platforms adaptable to regulated manufacturing environments, spanning virtual reality (VR), augmented reality (AR), and mixed reality modalities, according to BTI. The pilots will compare XR-based onboarding with established training approaches, with each CDMO applying the technology to its own manufacturing operations.

“The program allows us to help answer an important question: Can immersive learning improve how we prepare the next generation of biopharmaceutical manufacturing professionals, and can those improvements be measured through data?” says Vincent Villegas, senior director of commercial operations and strategy at JHS.

The CDMO pilots

KBI Biopharma’s participation in the program will focus on biosafety cabinet training, according to Brian Ridout, senior vice president and site head at KBI’s North Carolina facility.

The company chose biosafety cabinet training in part because the work requires technicians to understand how their hand movements and placement affect airflow around a product, which is something Prism’s XR technologies can help visualize through the pilot program.

The cabinet is also a critical focus of KBI’s contamination-control training. As a semi-open operation exposed to the surrounding environment, it is one of the most important areas for preventing contamination, Ridout says.

“This is a sterile environment where you have to be very spatially aware,” Ridout adds. “Your technique is very important, and it honestly takes lots of repetition to get good at this.”

That repetition can be difficult to accommodate in conventional training because opportunities to practice depend on production pace, how many iterations a trainee can fit in, and the availability of trainers to supervise trainees.

“Sometimes the process to be really confident and qualified takes too long. We see the opportunity for different technologies to supplement that standard learning process and really focus on knowledge acquisition and understanding of some of the nuances in a process that you can’t get without a lot of repetition,” Ridout observed.

Prism Immersive’s mixed-reality platform is designed to support that repetition through instructional materials — including educational videos and animations — as well as three-dimensional visualizations delivered via headset.

Through the visualization capabilities, trainees can see a digital representation of airflow moving around their hands and other objects inside a biosafety cabinet or isolator. Prism Immersive Chief Operating Officer Dan Beaupré described this capability as making “the invisible visible,” emphasizing the importance of this to the concept of first air in aseptic processing.

Kindeva is also evaluating Prism’s technology, bringing a different set of manufacturing applications to the program. The CDMO develops and manufactures products spanning pulmonary, nasal, sterile injectable, microneedle and transdermal drug delivery. Its pilot will compare XR-based onboarding with its established training protocols.

Meanwhile, Altoura’s collaboration with JHS will focus on aseptic manufacturing training for its new Line 4 isolator filling line in Spokane, Washington.

“Our recent expansion introduces advanced isolator manufacturing technology that is increasingly shaping the future of the industry. Because these systems are new to our site, they also create an opportunity to modernize how we prepare and train our workforce,” says Villegas.

JHS and Altoura are building a digital twin of the new line and developing training content around it. Employees will be able to move through a VR-based manufacturing environment and practice activities related to aseptic behavior, contamination control, cleanroom movement, gowning, and isolator interactions.

“Employees can practice responding to potential mistakes, see the consequences of improper actions, and repeat scenarios as many times as needed,” adds Villegas. “That kind of experiential learning has the potential to deepen understanding in ways that traditional classroom instruction alone may not achieve.”

Gauging pilot efficacy

The pilots are expected to run through June 2027, with each partnership assessing training outcomes based on technician performance and employee feedback.

Prism will evaluate the efficacy of the pilot program by examining employee time to proficiency, knowledge acquisition, and confidence, according to Beaupré. He said the company brought in SPEAR (STEM Program Evaluation, Assessment, Research) as an outside evaluator to compare groups receiving conventional training against those whose training is supplemented by XR.

The evaluation will also examine trainees’ knowledge of the equipment and processes involved. Confidence will be measured before and after the mixed-reality training, Beaupré noted.

JHS will also compare employees participating in its XR curriculum with those following traditional training. The company is approaching the pilot as a data-driven study, with plans to evaluate knowledge retention, training comprehension, skill proficiency, confidence, time to qualification and overall readiness to work in an aseptic manufacturing environment.

“Beyond the metrics, one of the most valuable aspects of this project is the opportunity to hear directly from the people completing the training,” Villegas says. “If team members feel better prepared, become proficient more quickly, and can perform their work with greater confidence and consistency, those are meaningful indicators that the technology is delivering real value.”

Building for the future

These pilots come amid growing demand for skilled biomanufacturing workers.

“When you think about workforce, there’s a supply and demand model, and the demand is highly outstripping the supply,” says Ridout.

Established companies are expanding their campuses while new companies enter the market, intensifying competition for talent, Ridout contends. That competition increases the need to prepare technicians for specialized roles.

XR presents an opportunity to help accelerate onboarding by giving employees opportunities to build knowledge before entering the manufacturing environment. Prism had previously developed training tools for community colleges and integrated them into their curricula, which offered students a way to build familiarity with equipment and processes before hands-on training, says CEO Jared DeCoste.

But in developing technologies for biosafety cabinet training, Prism also observed differences in how aseptic technique was taught across institutions, with Beaupré noting that there was “a fair amount of variation from one institution to another on aseptic technique inside a biosafety cabinet.” He says that training simulations built around established procedures could help provide a more consistent foundation.

“That’s very interesting: variation in aseptic technique in biosafety cabinets. Is that a good thing? Probably not,” Beaupré argues.

Ridout also sees potential for XR to support training beyond initial onboarding of new technicians.

“We see an opportunity here to potentially expand on the different modalities that we're putting in front of a person,” he says. “Whether they’ve got 20 years under their belt, or they’re coming in with a science or engineering degree, or maybe they’re changing careers.”

However, there are still limits to what XR can teach. DeCoste says some tasks, including putting on sterile gloves and sleeves and learning to pipette, do not translate as well to a virtual environment and still require physical practice.

“We’re not trying to replace hands-on training by any stretch of the imagination. Our goal is to augment it,” DeCoste adds.